FDA.reportPublic FDA data

Monoplus

Primary DI
04038653984510
Brand
Monoplus
Company
B BRAUN SURGICAL SA
Model
X0024524
Catalog number
X0024524
Device description
MONOPLUS VIOLET 4/0 (1.5) 70CM DR15 (M)
Published
2015-08-26
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NEWSUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NEWSuture, Surgical, Absorbable, PolydioxanoneGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04038653984510PrimaryGS10
04045439044283Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038653984510040386539845104038653984510
04045439044283040454390442834045439044283

GMDN Terms#

Term, Definition table
TermDefinition
Polyester suture, bioabsorbable, monofilament, non-antimicrobialA single-strand (monofilament), synthetic, bioabsorbable thread made from a polyester (e.g., polydioxanone, poliglecaprone, polycaprolactone, polyglyconate, polyhydroxybutyrate) intended to join (approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues. The thread provides extended temporary wound support, until the wound sufficiently heals to withstand normal stress, and is subsequently absorbed by hydrolysis; it may include an attached disposable needle. It is not a barbed suture and does not include antimicrobial agents/materials. This is a single-use device intended to be used in a sterile condition.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Length70Centimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)282-9000GUDID.BBMUS_Service@bbraun.com

Regulatory Flags#

DUNS number
511268005
Device count
4
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04046964732546MONOMAXB0041004B00410042018-05-03
04038653926190SteelexG0992100G09921002015-08-20
04046955081417OPTILENEB3095923B30959232022-10-04
04046955081653OPTILENEC3090272C30902722022-10-04
04046955081714OPTILENEC3090304C30903042022-10-04
04046964617331MONOSYNC2022015C20220152018-05-03
04046964618635MONOSYNC2022215C20222152018-05-03
04046964623615MONOSYNC2023424C20234242018-05-03
04046963043780DAFILONB0938920B09389202022-03-09
04046963117856DAFILONB0935890B09358902022-03-09
04046963929848DAFILONB0938905B09389052022-03-09
04046963042455DAFILONB0931640B09316402022-03-09
04046963043384DAFILONB0935739B09357392022-03-09
04038653945849SafilG1048388G10483882015-08-23
04046964028410MonomaxB9972005B99720052015-08-11
04046964028434MonomaxB9941967B99419672015-08-11
04046964028458MonomaxB9972004B99720042015-08-11
04046964028472MonomaxB9941966B99419662015-08-25
04046964066764MonomaxB9941249B99412492015-08-25
04046964066788MonomaxB9941258B99412582015-08-11

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Primary DI, Brand, Company table
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28800145524203Miracu FCL FORTE 19Gx70mm Feeltech Co.,Ltd.NEW2026-02-26
28800145524210Miracu FCL FORTE 19Gx100mm Feeltech Co.,Ltd.NEW2026-02-26
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28800145524302Miracu FCV Line 17Gx70mm Feeltech Co.,Ltd.NEW2026-02-26
28800145524319iracu FCV Line 17Gx100mm Feeltech Co.,Ltd.NEW2026-02-26
28800145524395Miracu MONO 27Gx40mm FDAFeeltech Co.,Ltd.NEW2026-02-26
28800145524401Miracu MONO 27Gx50mm FDAFeeltech Co.,Ltd.NEW2026-02-26
28800145524425Miracu MONO 27Gx60mm FDAFeeltech Co.,Ltd.NEW2026-02-26
28800145524432Miracu MONO 27Gx90mm FDAFeeltech Co.,Ltd.NEW2026-02-26
28800145524456Miracu MONO 29Gx40mm FDAFeeltech Co.,Ltd.NEW2026-02-26
28800145524470Miracu MONO 29Gx50mm FDAFeeltech Co.,Ltd.NEW2026-02-26
28800145524487Miracu MONO 29Gx60mm FDAFeeltech Co.,Ltd.NEW2026-02-26
30705031470624PDSETHICON, LLCNEW2026-01-29
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